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Results For "United-States"

913 News Found

Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra
Policy | August 27, 2025

Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra

The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion


Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection
Drug Approval | August 26, 2025

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited


Roche’s US subsidiary Genentech breaks ground on $700 million manufacturing facility in North Carolina
News | August 26, 2025

Roche’s US subsidiary Genentech breaks ground on $700 million manufacturing facility in North Carolina

The $700 million project is part of Roche’s $50 billion investment in US manufacturing, infrastructure and R&D


FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy
Drug Approval | August 25, 2025

FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy

KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB


FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients
Drug Approval | August 18, 2025

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo


UFlex posts Q1 FY26 PAT at Rs. 58 Cr
News | August 17, 2025

UFlex posts Q1 FY26 PAT at Rs. 58 Cr

The company’s virgin PET chips plant in Egypt, commissioned in Q4 FY25, achieved 74.8 per cent capacity utilization in its first full quarter. In India, the Panipat facility operated at 96.6 per cent utilization


Glenmark Pharmaceuticals reached $37.75 million settlement in antitrust litigation in US
News | August 12, 2025

Glenmark Pharmaceuticals reached $37.75 million settlement in antitrust litigation in US

Glenmark USA is named in multiple antitrust and consumer protection lawsuits, including class actions, consolidated in the Eastern District of Pennsylvania, U.S


Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags
Drug Approval | August 12, 2025

Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp


Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial
Drug Approval | August 12, 2025

Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA